Napralief 250mg Gastro-resistant Tablets 9s

This product is for short term use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.

Always take this medicine exactly as described in the leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The tablets should be taken with or after food and should be swallowed whole (not to be broken or crushed) preferably with a drink of water. Do not chew the tablets.

Adults 18-50 years for muscle, joint or tendon problems and period pain:

• The initial dose is 500mg (2 tablets), followed by 250mg (1 tablet) every 6 to 8 hours as needed. 
• Do not take more than 3 tablets per day.
• Do not take for longer than 3 days unless your doctor tells you to. Check with your doctor or pharmacist if you are not sure.
• You should make sure that you have enough to drink (stay well hydrated) when you are taking Napralief 250mg Gastro-resistant Tablets. This is particularly important for people who have problems with their kidneys.

• Active Ingredient: Naproxen 250mg
• Other Ingredients: Microcrystalline cellulose PH 101, croscarmellose sodium, povidone, magnesium stearate, methacrylic acid ethylacrylate copolymer (1:1) dispersion 30%, sodium hydroxide, triethyl citrate and talc.

• Napralief 250mg Gastro-resistant Tablets are not recommended for use in children under 18 years of age.
• Napralief 250mg Gastro-resistant Tablets may make you feel tired, drowsy, dizzy and cause changes in vision. If affected, do not drive or operate machinery.
• Napralief 250mg Gastro-resistant Tablets contains sodium This medicine contains less than 1 mmol sodium (23mg) per 250mg Tablet, that is to say essentially 'sodium-free'.
• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• Do not take Napralief 250mg Gastro-resistant Tablets if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and cause labour to be later or longer than expected.
• You should not take Napralief 250mg Gastro-resistant Tablets during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, Napralief 250mg Gastro-resistant Tablets can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.
• Napralief 250mg Gastro-resistant Tablets may make it more difficult to become pregnant. You should tell your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Do not take Napralief 250mg Gastro-resistant Tablets if:

• You are allergic (hypersensitive) to naproxen, naproxen sodium or any of the other ingredients.
• You are allergic (hypersensitive) to aspirin, other NSAIDs or any other pain relief medicines (such as ibuprofen or diclofenac).
• You have now or have ever had any problems with your stomach or gut (intestine) like an ulcer or bleeding.
• You have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking ibuprofen, aspirin or similar medicines.
• You have had gastrointestinal bleeding or perforation when previously taking NSAIDs (Non-steroidal anti-inflammatory drugs).
• You have severe liver or kidney problems.
• You have heart problems, high blood pressure or blood coagulation disorder.
• You have breathing difficulties.
• You are in the last three months of pregnancy.

Talk to your doctor or pharmacist before taking Napralief 250mg Gastro-resistant Tablets:

• If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
• If any of the following apply to you:
  
  • Asthma or allergies (like hayfever) or have had swelling of the face, lips, eyes or tongue in the past.
  • A feeling of weakness (perhaps because of an illness) or you are an older person.
  • Lumps in your nose (polyps) or you sneeze a lot or have a runny, blocked, or itchy nose (rhinitis).
  • Problems with your kidneys or liver.
  • Problems with the way that your blood clots.
  • Problems with the blood vessels (arteries) anywhere in your body.
  • Too much fat (lipid) in your blood (hyperlipidaemia).
  • An autoimmune condition, such as ‘systemic lupus erythematosus’ (SLE, causes joint pain, skin rashes and fever) and ulcerative colitis or Crohn's disease (conditions causing inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss).
  • Are in the first 6 months of pregnancy.
  • Have an infection. This medicine may hide signs of infections such as fever and pain. It is therefore, possible that this medicine may delay appropriate treatment of infection, which may lead to an increased risk of complications. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.
  • Skin reactions. Serious skin reactions including (Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS)) have been reported in association with Naproxen Tablets. Stop using Napralief 250mg Gastro-resistant Tablets and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions.

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Napralief 250mg Gastro-resistant Tablets.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. In particular, tell your doctor or pharmacist if you are taking:

• Other pain killers, like Aspirin/acetylsalicyclic acid, ibuprofen, diclofenac and paracetamol.
• Medicine to stop your blood clotting, like Aspirin/ acetylsalicyclic acid, warfarin, heparin or clopidogrel.
• A hydantoin (for epilepsy), like phenytoin.
• Sulfonamide medicines, like hydrochlorothiazide, acetazolamide, indapamide and including sulfonamide antibiotics (for infections).
• A sulfonylurea (for diabetes), like glimepiride or glipizide.
• An 'ACE inhibitor' or any other medicine for high blood pressure like cilazapril, enalapril or propranolol.
• An angiotensin-II receptor antagonist, like candesartan, eprosartan or losartan.
• A diuretic (water tablet) (for high blood pressure), like furosemide.
• A 'cardiac glycoside (for heart problems), like digoxin.
• A steroid (for swelling and inflammation), like hydrocortisone, prednisolone and dexamethasone.
• A 'quinolone antibiotic' (for infections), like ciprofloxacin or moxifloxacin.
• Certain medicines for mental health problems like lithium or 'SSRIs' like fluoxetine or citalopram.
• Probenecid (for gout).
• Methotrexate (used to treat skin problems, arthritis or cancer).
• Ciclosporin or tacrolimus (for skin problems or after an organ transplant).
• Zidovudine (used to treat AIDS and HIV infections).
• Mifepristone (used to end pregnancy or to bring on labour if the baby has died). Napralief 250mg Gastro-resistant Tablets should not be taken within 8-12 days of taking mifepristone.
• Antacids (to treat heartburn).
• Colestyramine (for high cholesterol) (take naproxen 1 hour before or 4 to 6 hours after colestyramine to avoid interference with absorption).

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Napralief 250mg Gastro-resistant Tablets.